Best Practices for Off-Label Marketing of Pharmaceuticals

• By: Staff Editor
• Date: September 30, 2011

Off-label use is the practice of prescribing drugs for an unapproved condition or in an unapproved age group, unapproved dose or unapproved form of administration.  Unlike the drugs approved by the Food and Drug Administration (FDA), off-label drugs do not undergo mandatory clinical trials to determine the dosages, efficacy, or side effects.

This article discusses the best practices to be followed in the off-label marketing of drugs.